Request for Proposals for an Educational Activity: “Tumor Hypoxia” To be held in conjunction with the Connective Tissue Oncology Society (CTOS) Annual Meeting November 4-7, 2015 Salt Lake City, UT 13778.1 Request for Proposals EMD Serono Commitment to Medical Education EMD Serono, Inc. is a scientific and educational leader in our therapeutic areas of interest. EMD Serono, Inc. is aware of the ongoing need for support for accredited continuing medical education. We understand that continuing medical education is the foundation for health care providers to provide quality, effective, and safe health care to their patients. EMD Serono Commitment to Independence in Medical Education EMD Serono, Inc. is committed to the independence of medical education. In awarding a grant, EMD Serono will make no grant as a reward or in exchange for prescribing or purchasing EMD Serono products or to induce the prescription or purchase of EMD Serono products in the future. Grant recipients are not expected or obliged to prescribe, purchase, or recommend an EMD Serono product. To maintain the independence of medical education programs it funds, EMD Serono will not exercise any control over or influence the educational program organization, operation, content, materials, faculty, speakers, presenters, moderators, audience or venue. All Grant Recipients, in accordance with the Grant Recipients’ guidelines, will take responsibility for and control over: the identification of educational needs; determination of educational objectives; selection of content, faculty or other persons and organizations that will be in a position to control the content of the activity, educational methods, materials, target audience and venue; evaluations; and presentation of content. Purpose and Scope of this Request for Proposals The EMD Serono Medical Education and Grants Office is seeking proposals for consideration that address the following educational needs: I. Disease Area Tumor Hypoxia In contrast to the well-ordered microvascular architecture of normal tissue, the microvascular network and other components of the microenvironment within tumor tissue are usually structurally disorganized. In addition, tumor cells proliferate rapidly and often have the potential to outgrow the development of the tumor blood capillaries, reducing the vascular density and creating a population of tumor cells that are distant from the tumor vasculature. As a consequence there are areas within tumors where oxygen and many conventional anticancer agents are unable to penetrate.1 One of the consequences of compromised oxygen delivery is the development of areas of hypoxia, which are a common feature of solid tumors.2 These areas are distributed heterogeneously within tumors and are independent of tumor characteristics such as size, stage, histology, and grade.Error! Bookmark not defined.,3 Furthermore, they are associated not only with reduced cell proliferation, but also, paradoxically, with the development of an aggressive, invasive, and metastatic tumor phenotype.Error! Bookmark not defined. Under conditions of cell hypoxia, genomic instability can lead to tumor cell variants that can survive in an oxygen depleted environment through clonal selection and expansion.Error! Bookmark 13778.1 2 not defined.,2 This clonal expansion can lead to tumor progression, poorer clinical outcomes (e.g. hypoxic cervical cancer, soft tissue sarcoma and squamous cell carcinoma of the head and neck).Error! Bookmark not defined. and acquired resistance to chemotherapy.Error! Bookmark not defined. The focus of this RFP is on identifying innovative continuing medical education (CME) and continuing professional development (CPD) programs addressing the role of hypoxia in tumor biology and its clinical implications. EMD Serono expects medical education providers to independently identify evidence-based professional practice gaps that shall serve as the basis for developing educational objectives for proposed medical education programs. Audience Medical education programs proposed in response to this RFP should address the learning needs of the following HCP audience: HCPs involved or interested in tumor hypoxia. Educational approach Medical education programs submitted in response to this RFP should meet the educational needs of the stated target audience and address evidence-based professional practice gaps in HCPs’ knowledge, skills and/or performance. Provider organizations should clearly state which precise learning formats shall be applied to address each specific professional practice gap identified. Whenever possible, provider organizations are encouraged to integrate their programs into a curriculum based strategy for life-long learning. Outcome measurement EMD Serono prefers to support medical education provider organizations capable of performing outcome measurements to assess the learning effectiveness of their programs. A minimum of level 3, preferably level 4 on the Moore’s scale is favored.5 In the detailed proposal, provider organizations should clearly specify how and to which level they plan to measure learning effectiveness for each identified professional practice gap. Eligibility Only Accredited CME providers are eligible to respond to this RFP. No individual HCPs, HCP practice groups, HCP-owned clinics, Managed Care Organizations or Pharmacy Benefit Managers may apply for a grant. Deadline for Submission of Grant Application The deadline for submitting a grant application in connection with this Request for Proposals is July 31, 2015. How to Respond to this Request for Proposals Requests must be submitted through EMD Serono’s Request Management website, www.grants.emdserono.com. If you are not yet a registered user, click on “register” and create a user profile. If you have any questions, please contact us by phone (1-800-283-8088) or email (megrants@emdserono.com). Completing the Grant Application on the Request Management Website The information below will help you fill out the particular sections of the online grant application. “General Information” Section of the Request Application Complete all information requested under the “General Information” section. 13778.1 3 “Program Overview” Section of the Grant Application Complete all information requested under the “Program Overview” section. This section relates to the program that your organization is proposing in response to this Request for Proposals. Below is specific guidance on certain fields in this section: Budget Proposals should not exceed $250,000 USD Event Start and End Dates Potential dates for the start and end of the program, taking into account necessary planning time. Total Credit Hours and Number of Attendees Information should be based on good faith estimates. Please Note: A complete reconciliation will be required following the close of the program. Terms, Conditions and Disclaimers 1. The purpose of the Request for Proposals is to make CME providers and other qualified organizations aware that EMD Serono is interested in receiving grant applications through its Medical Education Program for an independent education program. It is not an offer to contract. Only the execution of a Grant Agreement by the CME provider/organization and EMD Serono will obligate EMD Serono and the provider/organization in accordance with the terms and conditions contained in the Grant Agreement. EMD Serono’s Standard Form of Grant Agreement is posted on the Grant Management website. 2. Per EMD Serono’s medical education grant policy, educational programs must be primarily dedicated, in both time and effort, to promoting objective scientific and educational activity and discussion. 3. Per EMD Serono’s medical education grant policy, individual professionals, physician group practices, physician-owned clinics, managed care organizations, and pharmacy benefit managers are not eligible to apply for accredited professional education grants. 4. All organizations must bear their own costs associated with responding to this Request for Proposals and submitting a grant application. 5. EMD Serono reserves the right to amend or terminate this Request for Proposals at any time and for any reason. EMD Serono reserves the right to not grant any of the grant applications submitted through the Grant Program. 6. EMD Serono reserves the right to verify all information provided by an organization in its grant application. 7. Grant Recipients shall be required to disclose that financial support was received from EMD Serono in invitations, brochures, advertisements and other written communications related to the educational activity. 8. In addition, the Grant Recipients shall be required to disclose the following information to attendees at the start of the educational activity: (1) EMD Serono’s financial support for the activity; (2) any financial relationships between the Grant Recipients, faculty, presenters, 13778.1 4 moderators or other person who is in a position to control the content of the educational activity and EMD Serono; and (3) whether any unapproved uses of products will be discussed. 9. The award of Educational Grants shall be conditioned on the Grant Recipient’s consent to public disclosure of the Educational Grant on EMD Serono’s website. The website disclosure will include the Grant Recipient’s name, a brief description of the activity for which the Educational Grant was provided, and the amount of the Educational Grant. The website disclosure will be updated quarterly. 13778.1 5